UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028114 |
|---|---|
| Receipt number | R000032185 |
| Scientific Title | Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2021/08/03 11:15:54 |
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Basic information
Public title
Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Acronym
A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Scientific Title
Comparison of decompression, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis: a prospective, randomized study
Scientific Title:Acronym
A prospective randomized study of surgical treatment for degenerative spondylolisthesis
Region
| Japan |
Condition
Condition
Degenerative spondylolisthesis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The selection of surgical procedure for lumbar spinal stenosis due to degenerative spondylolisthesis is still under debate. The purpose of this study is to prospectively assess the clinical results of decompression alone, decompression plus fusion, and decompression plus stabilization for degenerative spondylolisthesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical outcomes were evaluated by JOA score, VAS, and SF-36 before surgery, at 1 year and 5, 10 years after surgery .
Key secondary outcomes
Amount of bleeding, operation time, and radiological evaluations etc were evaluated
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Decompression
Interventions/Control_2
Decompression and fusion
Interventions/Control_3
Decompression and stabilization
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
One level lumbar spinal stenosis due to degenerative spondylolisthesis
Key exclusion criteria
Previous history of lumbar spinal operation
Multilevel stenosis
Foraminal stenosis
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Inose |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
inose.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Inose |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopedic Surgery
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
Homepage URL
inose.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 09 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032185
